This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
ABT-263 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle; Fludarabine will be given by intravenous infusion for 3 days out of each 28 day cycle; and Cyclophosphamide will be given by intravenous infusion for 3 days out of each 28 day cycle
Rituximab will be given by intravenous infusion for 2 days out of each 28 day cycle and Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle
Site Reference ID/Investigator# 17841
La Jolla, California, United States
Site Reference ID/Investigator# 25899
Stanford, California, United States
Site Reference ID/Investigator# 21622
Baltimore, Maryland, United States
Site Reference ID/Investigator# 21621
Columbus, Ohio, United States
Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL.
Time frame: Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days
Evaluate preliminary data regarding progression-free survival (PFS), tumor response rate and overall survival (OS) when ABT-263 is administered in combination with either FCR or BR.
Tumor assessments
Time frame: Every 2 months
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Site Reference ID/Investigator# 39613
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 17943
Houston, Texas, United States